Jobs at Syndax Pharmaceuticals

Leads supplier quality management for GxP service providers, suppliers, contract laboratories, distribution partners, and outsourced vendors. Responsibilities include risk-based supplier qualification, audits, lifecycle oversight, quality metrics, quality technical agreements, corrective actions, inspection readiness, and regulatory compliance. The role collaborates with Quality, Supply Chain, Regulatory, Clinical Operations, Pharmacovigilance, IT, and external partners while supporting supply chain expansion, vendor transitions, and continuous improvement.

Provides expert statistical programming support for clinical trials and drug programs using SAS. Produces and validates tables, listings, figures, CRF tabulations, pooled analyses, biomarker and HEOR analyses, and regulatory responses. Collaborates with biostatisticians, data managers, vendors, and cross-functional teams while ensuring compliance with statistical analysis plans, CDISC standards, FDA regulations, ICH guidelines, and applicable regulatory requirements.

Oversee GMP quality activities for investigational drug substances, drug products, and clinical finished goods manufactured by external partners. Review batch, testing, packaging, labeling, and release documentation; manage deviations, investigations, CAPAs, change controls, complaints, and OOS/OOT events. Partner cross-functionally to mitigate compliance and patient-safety risks, support clinical supply continuity, author quality documents, and ensure regulatory and company quality-system compliance.

Leads strategic outsourcing for clinical and CMC development programs, including vendor selection, RFI/RFP processes, contract and work order negotiations, procurement activities, budget and spend oversight, vendor performance tracking, governance, and closeout. Partners with Clinical Operations, CMC, Supply Chain, Finance, Procurement, and Legal while improving outsourcing processes and reporting across R&D.